Tag: clearance
Withings receives clearance for smart BPM
December 17, 2024HME News Staff
BOSTON – Withings Health Solutions, the professional health care division of Withings, has announced that its BPM Pro 2, a cellular blood pressure monitor that integrates and automates many aspects of clinical workflows, is now cleared by the U.S. Food and Drug Administration. The BPM Pro 2 is now cleared to measure blood pressure and pulse rate in adults with arm circumferences of nine to 17 inches or 16 to 20 inches. “We are thrilled BPM Pro 2 is now FDA-cleared, this device marks a...
Senseonics, Ascensia launch one-year CGM system
September 17, 2024HME News Staff
GERMANTOWN, Md., and PARSIPPANY, N.J. – Senseonics and Ascensia Diabetes Care have announced that the U.S. Food and Drug Administration has cleared the next-generation Eversense 365 CGM, the first one-year CGM system. “The approval of Eversense 365 represents a significant leap in CGM innovation,” said Tim Goodnow, PhD, president and CEO of Senseonics. “Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides...